Balloon catheter integrating lung biopsy and hemostasis through bronchoscope freezing

By designing a transbronchioscopic cryoplasty and integrated balloon catheter with hemostasis integrated balloon catheter with integrated cryoprobe, drug balloon and guidewire channel, the problems of bleeding and precise positioning after biopsy are solved, efficient hemostasis and high-quality sample acquisition are achieved, simplifying the surgical process and improving safety and efficiency.

CN119632604APending Publication Date: 2025-03-18FUWAI HOSPITAL CHINESE ACAD OF MEDICAL SCI & PEKING UNION MEDICAL COLLEGE
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Patent Information

Application Number
CN202411947089.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-27
Publication Date
2025-03-18

AI Technical Summary

Technical Problem

The prior art has complicated steps to stop bleeding after biopsy of lung tissue samples, and the hemostasis effect is poor, the inability to accurately locate or position biopsy, and the difficulty in obtaining biopsy samples at the apical area of ​​the lung.

Method used

A balloon catheter integrated through bronchoscopic cryopresis and hemostasis is designed, integrating cryoprobe, drug balloon and guidewire channel, and compressing hemostasis is achieved through inflating the drug balloon. The biopsy site is accurately positioned using the guidewire channel, and hemostasis drugs are sprayed through the working channel.

Benefits of technology

It realizes effective control of bleeding during the biopsy process, reduces the risk of complications, obtains high-quality lung tissue samples, simplifies operating steps, reduces surgical risks, and improves the accuracy of the surgery and patient comfort.

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Abstract

The invention relates to a bronchoscope frozen lung biopsy and hemostasis integrated balloon catheter, belongs to the technical field of medical instruments, and solves the problems that in the prior art, operation steps are complicated and difficult, and a biopsy sample of a lung tip part is accurately obtained. The bronchoscope frozen lung biopsy and hemostasis integrated balloon catheter comprises a catheter body, wherein the catheter body is provided with a catheter head end and a catheter tail end; a working hole channel, a balloon channel and a guide wire channel which are independent from one another are integrated on the catheter main body; the working hole channel is configured as a channel when the freezing probe performs biopsy operation and is used for spraying a hemostatic medicine to a hemostatic part in an airway; a medicine balloon is arranged at the head end of the catheter, hemostatic particles are arranged on the outer surface of the medicine balloon, and the medicine balloon is communicated with the balloon channel and is configured to be inflated to expand the medicine balloon to achieve compression hemostasis; and a guide wire is arranged in the guide wire channel and is configured to guide the catheter main body to a target position. According to the application, the functions of freezing biopsy and instant hemostasis are integrated.
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Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and specifically relates to an integrated balloon catheter for transbronchial cryobiopsy and hemostasis. Background Art

[0002] Transbronchial Lung Biopsy (TBLB) and Transbronchial Cryobiopsy (TBCB) are two key techniques used in clinical practice to diagnose lung diseases, allowing doctors to obtain lung tissue samples for pathological examination. In the TBLB operation, which is usually performed under local anesthesia, the doctor inserts a bronchoscope into the patient's airway and uses biopsy forceps at the target lung tissue to obtain samples for pathological analysis. However, the TBLB technique can usually only obtain smaller tissue samples, limiting the accuracy and completeness of pathological analysis. TBCB, as a newer technique, usually requires patients to undergo surgery under general anesthesia. By using a cryoprobe, doctors can obtain larger and more complete lung tissue samples, which will then be thawed and pathologically diagnosed. With the increase in the detection rate of ground glass nodules and small solid nodules in the lungs, higher requirements are placed on transbronchial diagnostic techniques. However, the two commonly used techniques, TBLB and trans-TBCB, each have certain limitations, as follows: The main limitation of TBLB is that it can usually only obtain smaller tissue samples, which limits the depth and accuracy of pathological analysis, resulting in a relatively low diagnostic positive rate. In addition, the main complication risk of TBLB is bleeding, which is more common when performing biopsies of peripheral lung lesions. At present, bronchoscope biopsy forceps lack scale markings, and operators usually judge the distance between the lesion and the bronchoscope port based on experience, or measure the relative distance outside the bronchoscope. This method is relatively inaccurate for the precise positioning of the lesion; and the biopsy forceps are inserted too deeply, which also significantly increases the risk of bleeding. Moreover, bleeding after biopsy requires replacement of operating instruments to stop bleeding, and the operation steps are complicated.

[0003] In contrast, the TBCB technique can provide larger tissue samples, but it has a higher risk of bleeding, especially when using a larger diameter cryoprobe. To reduce the risk of massive bleeding, clinicians usually pre-place a hemostatic balloon in the bronchus near the target bronchus with the support of a rigid bronchoscope. After the TBCB operation is completed, the cryoprobe needs to be removed first and the balloon needs to be inflated quickly to compress and stop bleeding, but sometimes the hemostasis effect of the balloon alone is not good. In addition, in order to accurately determine the target lesion site, TBCB needs to be precisely positioned under the guidance of cone beam computed tomography (CBCT). This shows that the operation process of TBCB is more complicated, with higher requirements for equipment and operation techniques, and general anesthesia is usually required, which undoubtedly increases the complexity and risk of the operation. In addition, the TBCB technique often uses probes with an outer diameter of 2.4 mm and 1.9 mm, but there are still limitations in obtaining biopsy samples at the apex of the lung, and it is impossible to enter this area for biopsy samples.

[0004] To summarize the above analysis, when performing lung tissue biopsy with bronchoscopes in the prior art, there are problems such as the need to replace operating instruments to stop bleeding after biopsy, which is complicated and has a poor hemostasis effect; the biopsy cannot be accurately positioned or the biopsy positioning operation is complicated; and it is difficult to obtain biopsy samples at the apex of the lung. Summary of the invention

[0005] In view of the above analysis, an embodiment of the present invention aims to provide an integrated balloon catheter for transbronchoscope cryobiopsy and hemostasis, so as to solve the problems in the prior art of bronchoscope performing lung tissue sample biopsy, such as bleeding after biopsy, which requires replacing the operating instrument for hemostasis, complicated operation steps and poor hemostasis effect, inability to accurately locate the biopsy or complicated biopsy positioning operation, and difficulty in obtaining biopsy samples at the apex of the lung.

[0006] The object of the present invention is achieved in that: A transbronchoscope cryo-lung biopsy and hemostasis integrated balloon catheter comprises a catheter body, wherein the catheter body has a catheter head end and a catheter tail end; and the catheter body is integrated with independent working channels, balloon channels and guide wire channels; The working channel is configured as a passage for a cryoprobe to perform a biopsy operation and to spray hemostatic drugs to a hemostatic site in the airway; A drug balloon is provided at the catheter tip, and hemostatic drug particles are provided on the outer surface of the drug balloon. The drug balloon is connected to the balloon channel and is configured to expand the drug balloon by inflation to achieve compression hemostasis. A guidewire is arranged in the guidewire channel and is configured to guide the catheter body to a target position.

[0007] Furthermore, the outer diameter of the cryoprobe is 1.1 mm.

[0008] Furthermore, a plurality of hemostatic drug particles are evenly arranged on the outer surface of the drug balloon.

[0009] Furthermore, the channel inlet of the balloon channel is connected to the air pumping and deflation device, and the channel outlet of the balloon channel is connected to the medicine balloon, and the inflation and deflation of the medicine balloon are controlled by the air pumping and deflation device.

[0010] Furthermore, the channel inlet of the balloon channel is connected to the air extraction and deflation device through an adapter.

[0011] Furthermore, the outer surface of the catheter tip is provided with scale markings.

[0012] Furthermore, the scale mark has uniformly arranged scale lines, and the scale lines have a scale interval of 1 cm.

[0013] Furthermore, a one-way check valve is provided in the working channel of the catheter tip, and the one-way check valve is configured to prevent the backflow of liquid in the airway.

[0014] Furthermore, the one-way check valve, the drug balloon and the scale mark are arranged in sequence along the direction from the catheter head end to the catheter tail end.

[0015] Furthermore, the working channel has a working channel inlet, and the working channel inlet is detachably connected to a hemostatic drug injection device, which can spray hemostatic drugs through the working channel.

[0016] Furthermore, both the hemostatic drug injection device and the gas extraction and deflation device adopt a syringe.

[0017] Furthermore, the drug balloon comprises an airbag main body and a plurality of folding parts connected to the airbag main body, the airbag main body is sealingly connected to the outer wall of the catheter head end and forms a sealed space with the outer wall surface of the catheter head end, the sealed space is connected with the channel outlet of the balloon channel and the internal space of the folding part; when not inflated, the airbag main body and the folding part are both in a contracted state; when inflated, the folding part and the airbag main body can both expand and unfold into a spherical state.

[0018] Furthermore, the airbag main body and the folding part are both made of medical elastic material, and the outer surfaces of the airbag main body and the folding part are provided with hemostatic drug particles.

[0019] Furthermore, the hemostatic drug particles are in a convex structure, and the convex structure has a spike end; when the drug balloon is inflated and unfolded, the spike end of the hemostatic drug particles can be tilted toward the tail end of the catheter, forming a barb shape.

[0020] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects: a) The transbronchial cryobiopsy and hemostasis integrated balloon catheter provided by the present invention integrates the cryobiopsy and instant hemostasis functions, which can effectively control bleeding during the biopsy process, reduce the risk of complications, and obtain high-quality lung tissue samples. At the same time, it simplifies the operation steps, reduces the surgical risks, and simplifies the surgical operation.

[0021] b) The integrated transbronchial cryobiopsy and hemostasis balloon catheter provided by the present invention integrates a drug balloon at the catheter tip and controls the inflation and deflation of the drug balloon through a pumping and deflation device in the balloon channel, thereby promoting the release of hemostatic drug particles on the surface of the drug balloon, achieving efficient hemostasis during biopsy, improving the safety and efficiency of lung disease diagnosis, and significantly improving the accuracy of surgery and patient comfort through precise depth control and instant hemostasis mechanism.

[0022] c) The one-way check valve at the tip of the bronchoscopic cryobiopsy and hemostasis integrated balloon catheter provided by the present invention can effectively prevent the backflow of liquid in the airway and can be connected to a hemostatic drug injection device at the entrance of the working channel. The hemostatic drug injection device is used to evenly spray the hemostatic drug onto the airway surface through the working channel, which significantly improves the safety of the operation. In particular, when a 1.1mm cryoprobe is used for biopsy, the biopsy area can be quickly hemostatic, which greatly reduces the risk of bleeding, solves the common bleeding problem in TBCB, and improves the safety of the operation.

[0023] d) The integrated transbronchial cryobiopsy and hemostasis balloon catheter provided by the present invention enables biopsy and hemostasis to be completed on the same device, reducing the need to switch between different tools during surgery, thereby eliminating the use of a rigid bronchoscope, simplifying the operating steps and improving diagnostic efficiency; and it is easy to operate, allowing doctors to perform the operation under local anesthesia, reducing dependence on general anesthesia and rigid bronchoscopes, which not only improves surgical efficiency, but also reduces the economic burden and hospitalization time of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of this specification or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of this specification. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0025] Figure 1 A schematic diagram of the structure of the transbronchoscope cryobiopsy and hemostasis integrated balloon catheter provided by the present invention; Figure 2 A schematic cross-sectional view of a catheter body of the transbronchoscope cryobiopsy and hemostasis integrated balloon catheter provided by the present invention; Figure 3 A schematic diagram of the partial cross-sectional structure of the transbronchoscope cryobiopsy and hemostasis integrated balloon catheter provided by the present invention; Figure 4 A schematic diagram of the structure of the drug balloon provided by the present invention in an uninflated state; Figure 5 This is a schematic diagram of the structure of the drug balloon provided by the present invention in an inflated state.

[0026] Figure 6 A schematic diagram of the structure of the one-way check valve provided by the present invention; Figure 7 A cross-sectional schematic diagram of a one-way check valve provided by the present invention; Figure 8 It is a schematic diagram of the state of spraying hemostatic medicine through the spray port at the catheter head end of the present invention.

[0027] Reference numerals: 1. Working channel; 2. Balloon channel; 3. Guidewire channel; 4. Drug balloon; 401. Balloon body; 402. Folding part; 5. Hemostatic drug particles; 6. One-way check valve; 7. Hemostatic drug spray port; 8. Scale mark; 9. Adapter; 10. Extraction and exhaust device; 11. Guidewire inlet; 12. Working channel inlet. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. It should be noted that, in the absence of conflict, the embodiments in the present disclosure and the features in the embodiments can be combined, separated, interchanged and / or rearranged with each other. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0029] In the accompanying drawings, the size and relative size of components may be exaggerated for clarity and / or descriptive purposes. When the exemplary embodiments may be implemented differently, a specific process sequence may be performed in a different order than described. For example, two successively described processes may be performed substantially simultaneously or in an order opposite to the order described. In addition, the same reference numerals represent the same components.

[0030] The terms used here are for the purpose of describing specific embodiments, and are not intended to be restrictive. As used here, unless the context clearly indicates otherwise, the singular forms "one (kind, person)" and "said (the)" are also intended to include plural forms. In addition, when the terms "comprise" and / or "include" and their variations are used in this specification, it is explained that there are stated features, integral bodies, steps, operations, parts, assemblies and / or their groups, but it is not excluded that there are or add one or more other features, integral bodies, steps, operations, parts, assemblies and / or their groups. It should also be noted that, as used here, the terms "substantially", "approximately" and other similar terms are used as approximate terms and not as degree terms, so that they are used to explain the inherent deviations of the measured values, calculated values ​​and / or the values ​​provided that will be recognized by those of ordinary skill in the art.

[0031] Example 1 A specific embodiment of the present invention discloses an integrated balloon catheter for transbronchial cryobiopsy and hemostasis, hereinafter referred to as "integrated balloon catheter", which can be applied to the diagnosis and treatment of various respiratory diseases, especially in the field of interventional respiratory medicine, for biopsy of lung tissue and real-time hemostasis treatment.

[0032] like Figures 1 to 8 As shown, the integrated balloon catheter for bronchoscopic cryobiopsy and hemostasis includes a catheter body, which has a catheter head end and a catheter tail end; the catheter body is integrated with independent working channels 1, balloon channels 2 and guidewire channels 3; the working channel 1 is configured as a channel for the cryoprobe to perform biopsy operations and to spray hemostatic drugs to the hemostasis site in the airway; the catheter head end is provided with a drug balloon 4, the outer surface of the drug balloon 4 is provided with hemostatic drug particles 5, the drug balloon 4 is connected to the balloon channel 2, and is configured to expand the drug balloon 4 by inflation to achieve compression hemostasis; the guidewire channel 3 is provided with a guidewire, which is configured to guide the catheter body to the target position.

[0033] The existing technology has the risk of complications such as bleeding during lung biopsy, and reducing these risks is crucial to improving patient safety and the success rate of surgery. The integrated balloon catheter in this embodiment integrates multiple hemostatic mechanisms, and uses two hemostatic measures: a drug balloon 4 coated with hemostatic drugs on the surface and spraying hemostatic drugs to the hemostatic site in the airway through the working channel 1, which enhances the local hemostatic effect. The hemostatic drugs are evenly sprayed into the airway through the working channel 1, quickly controlling the bleeding during the biopsy and effectively reducing the risk of complications.

[0034] In this embodiment, the outer diameter of the cryoprobe is 1.1 mm, and the inner diameter of the working channel 1 is adapted to the outer diameter of the cryoprobe. By using the working channel 1 in conjunction with the cryoprobe with an outer diameter of 1.1 mm, the bronchoscope and the guide wire can be used to penetrate into the lung segments and subsegments, thereby obtaining larger lung tissue samples and ensuring the integrity of the samples to improve the accuracy of pathological analysis. Moreover, the use of a 1.1 mm diameter cryoprobe improves the flexibility of the operation, especially when the bronchoscope needs to be bent at a larger angle, making the biopsy process safer and more effective.

[0035] In this embodiment, the working channel 1 has a working channel inlet 12 and a working channel outlet. The working channel inlet 12 is detachably connected to a hemostatic drug injection device, and the hemostatic drug can be sprayed through the working channel 1. At this time, the working channel outlet serves as a hemostatic drug spraying port 7. The spraying state is shown in FIG. Figure 8 Optionally, the hemostatic drug injection device uses a syringe. By using the working channel 1 and the hemostatic drug injection device integrated in the catheter body as a hemostatic drug delivery system, hemostatic drugs or other therapeutic drugs can be directly delivered to the biopsy area during or after the biopsy to enhance the hemostatic effect or provide additional therapeutic benefits.

[0036] In this embodiment, a plurality of hemostatic drug particles 5, such as hemocoagulase, are evenly arranged on the outer surface of the drug balloon 4. The drug balloon 4 can be used to incarcerate the target subsegmental bronchus, and the hemostatic drug particles 5 on the surface of the drug balloon 4 can increase the contact friction between the drug balloon 4 and the inner wall of the airway, which is conducive to the fixation of the drug balloon 4; when the drug balloon 4 is inflated through the balloon channel 2, the expanded drug balloon 4 can compress and stop bleeding, and the release of the hemostatic drug particles 5 can further increase the hemostatic effect.

[0037] In this embodiment, the channel inlet of the balloon channel 2 is connected to the air extraction and deflation device 10, and the channel outlet of the balloon channel 2 is connected to the drug balloon 4, and the inflation and deflation of the drug balloon 4 are controlled by the air extraction and deflation device 10. The size of the drug balloon 4 is adjustable, allowing the doctor to adjust the size of the drug balloon according to the needs of the operation to adapt to different surgical situations, providing more flexibility. Optionally, the air extraction and deflation device 10 can use a syringe to perform the inflation operation of the drug balloon 4 to achieve a hemostatic function. Further, the channel inlet of the balloon channel 2 is connected to the air extraction and deflation device 10 through an adapter 9. Furthermore, the adapter 9 has a valve, and when the drug balloon is inflated, the valve is closed to disconnect the balloon channel 2 from the syringe, so that the inflated drug balloon is in a continuously filled state.

[0038] In one optional embodiment, the drug balloon 4 has an airbag main body 401 and a plurality of folding parts 402 connected to the airbag main body 401, the airbag main body 401 and the folding parts 402 are both made of medical elastic material, and the outer surfaces of the airbag main body 401 and the folding parts 402 are provided with hemostatic drug particles 5; the airbag main body 401 is sealed and connected to the outer wall of the catheter head end and forms a sealed space with the outer wall surface of the catheter head end, and the sealed space is connected with the channel outlet of the balloon channel 2 and the internal space of the folding part 402; when not inflated, refer to Figure 4 , the airbag main body 401 and the folded portion 402 are both in a contracted state; when inflated, see Figure 5 , the folding portion 402 and the airbag main body 401 can both be expanded and unfolded into a spherical state.

[0039] In one optional embodiment, the hemostatic drug particles 5 are convex structures, and the convex structures have spiked ends; when the drug balloon 4 is inflated and deployed, the spiked ends of the hemostatic drug particles 5 can be tilted toward the tail end of the catheter, forming a barb shape. With this structural arrangement, the spiked ends of the hemostatic drug particles 5 do not damage the tracheal lining tissue, but can further enhance the connection stability between the drug balloon 4 and the tracheal lining, thereby preventing the position of the drug balloon 4 from moving before the hemostatic drug particles 5 take effect, and ensuring the reliability of the hemostatic effect.

[0040] The prior art is insufficient in accurately locating the distance between the lesion site and the lens under the microscope, which affects the accuracy of the biopsy. Therefore, improving the accuracy of the biopsy site is crucial to ensure that the most representative tissue sample is obtained. Based on this, in this embodiment, a scale mark 8 is provided on the outer surface of the catheter tip. The scale mark 8 provides an intuitive visual reference for the doctor, so that the operator can determine the depth of the target bronchus from the catheter tip in combination with chest imaging examination before surgery, thereby intuitively and accurately controlling the depth of the biopsy during surgery, ensuring the quality of the sample and the safety of the operation, and reducing the risk of complications. Furthermore, the scale mark 8 has evenly arranged scale lines, and the scale spacing of the scale lines is 1 cm.

[0041] In one optional embodiment, Figure 6 As shown, a one-way check valve 6 is provided in the working channel 1 at the catheter head end, and the one-way check valve 6 is configured to prevent the backflow of liquid in the airway. When the hemostatic drug is quickly injected from the working channel inlet 12 to mix with air using a hemostatic drug injection device, a mist of hemostatic drug can be evenly sprayed out from the hemostatic drug spray port 7 at the catheter head end. Specifically, the one-way check valve 6, the drug balloon 4 and the scale mark 8 are arranged in sequence along the direction from the catheter head end to the catheter tail end. The hemostatic drug sprayed through the working channel 1 can pass through the one-way check valve 6 located inside the catheter head end. The one-way check valve 6 can also prevent the backflow of liquid, reducing the risk of the liquid in the airway backflowing into the integrated balloon catheter due to the patient's violent coughing.

[0042] In this embodiment, an independent guidewire channel 3 is integrated on the catheter body of the integrated balloon catheter, which can smoothly guide the catheter body into the target bronchus without affecting the working channel 1, and can accurately locate the biopsy position before surgery. The introduction of an independent guidewire channel further improves the flexibility of operation and meets the clinical demand for efficient and safe lung biopsy technology. The channel entrance of the guidewire channel 3 is connected to a guidewire entrance 11, which is connected to the tail end of the catheter and is used to introduce a guidewire to guide the catheter body to the target position, thereby improving the operational flexibility and realizing the guiding operation of complex paths.

[0043] The specific use process of bronchoscopic cryobiopsy and hemostasis integrated balloon catheter is as follows: (1) Preoperative preparation: The target biopsy site is determined by CT imaging, and its distance from the adjacent pulmonary segment and subsegmental bronchus is measured to facilitate precise control of the biopsy depth during surgery.

[0044] (2) Bronchoscope positioning: The bronchoscope is sent to the adjacent pulmonary subbronchial opening of the target lung segment to provide precise guidance for the insertion of the catheter.

[0045] (3) Catheter insertion: Insert the integrated balloon catheter into the target lung segment through the working channel of the bronchoscope. Adjust the depth of the catheter according to the distance measured before the operation. Use the guidewire inlet 11 to introduce a guidewire as a guide to ensure that the catheter reaches the target position accurately.

[0046] (4) Inflation of the drug balloon 4: The drug balloon 4 is inflated by the air pumping and deflation device 10, and the drug balloon 4 is embedded in the target subsegmental bronchus. The hemostatic drug particles 5 on the surface of the drug balloon 4 are released to prevent bleeding during the biopsy process and achieve immediate hemostasis.

[0047] (5) Cryobiopsy: A 1.1 mm cryoprobe is inserted into the working channel 1 through the working channel entrance 12 to perform a cryobiopsy and obtain high-quality lung tissue samples.

[0048] (6) Postoperative treatment: After the biopsy is completed, if necessary, hemostatic drugs can be injected through the working channel inlet 12 and evenly sprayed into the airway through the spray port 7 to enhance the hemostatic effect and ensure the safety of the operation.

[0049] Compared with the prior art, the transbronchial cryobiopsy and hemostasis integrated balloon catheter provided in this embodiment can achieve at least one of the following beneficial effects: 1. Integrated cryobiopsy and instant hemostasis function: By integrating a cryobiopsy probe with an outer diameter of 1.1 mm, a hemostatic drug balloon, and a hemostatic drug spray port in a catheter body, the safety and efficiency of the operation are significantly improved, and the complexity of replacing operating instruments for hemostasis after bleeding in TBLB or TBCB is solved. In addition, the use of a cryoprobe with a diameter of 1.1 mm ensures that sufficient tissue samples are obtained and reduces the risk of bleeding.

[0050] 2. The scale marks on the catheter tip provide doctors with an intuitive visual reference, allowing them to accurately control the depth of the biopsy during the biopsy process. The scale marks help improve the accuracy and consistency of sample acquisition, while also avoiding the risk of blindly inserting the biopsy probe too deep and increasing the risk of pneumothorax.

[0051] 3. The one-way check valve installed at the catheter tip can effectively prevent the backflow of liquid in the airway, reducing the risk of occupational exposure for the operator.

[0052] 4. Easy operation simplifies the surgical process. The entire operation process does not require frequent switching of instruments to deal with complications, thus reducing dependence on rigid bronchoscopes and allowing doctors to perform operations under local anesthesia, improving the convenience of surgery and the comfort of patients.

[0053] 5. By setting up an independent guidewire channel in the catheter body, the guidewire can be used to accurately and flexibly guide the catheter body to difficult-to-reach locations (such as the apical and posterior segments of the upper lobe of the lung) without occupying the working channel. After the catheter body is in place, a stable biopsy pathway will be established, thereby improving the success rate of biopsy in difficult locations.

[0054] The specific implementation methods described above further illustrate the purpose, technical solutions and beneficial effects of the present application in detail. It should be understood that the above description is only the specific implementation method of the present application and is not intended to limit the scope of protection of the present application. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A bronchoscopic cryobiopsy and hemostasis integrated balloon catheter, characterized in that: The catheter body comprises a catheter head end and a catheter tail end; the catheter body is integrated with independent working channels, balloon channels and guidewire channels; The working channel is configured as a passage for the cryoprobe to perform a biopsy operation and to spray hemostatic drugs to the hemostatic site in the airway; The catheter head end is provided with a drug balloon, the outer surface of which is provided with hemostatic drug particles, the drug balloon is communicated with the balloon channel, and is configured to expand the drug balloon by inflation to achieve compression hemostasis; A guidewire is arranged in the guidewire channel and is configured to guide the catheter body to a target position.

2. The bronchoscopic cryobiopsy and hemostasis integrated balloon catheter according to claim 1, characterized in that: The outer diameter of the cryoprobe is 1.1 mm.

3. The bronchoscopic cryobiopsy and hemostasis integrated balloon catheter according to claim 1, characterized in that: The channel inlet of the balloon channel is connected to the air pumping and deflation device, and the channel outlet of the balloon channel is communicated with the medicine balloon, and the inflation and deflation of the medicine balloon are controlled by the air pumping and deflation device.

4. The bronchoscopic cryobiopsy and hemostasis integrated balloon catheter according to claim 3, characterized in that: The outer surface of the catheter head end is provided with scale markings.

5. The transbronchial cryobiopsy and hemostasis integrated balloon catheter according to claim 4, characterized in that: A one-way check valve is arranged in the working channel of the catheter tip, and the one-way check valve is configured to prevent the backflow of liquid in the airway.

6. The transbronchial cryobiopsy and hemostasis integrated balloon catheter according to claim 5, characterized in that: The one-way check valve, the drug balloon and the scale mark are arranged in sequence along the direction from the catheter head end to the catheter tail end.

7. The transbronchial cryobiopsy and hemostasis integrated balloon catheter according to claim 6, characterized in that: The working channel has a working channel entrance, and the working channel entrance is detachably connected to a hemostatic drug injection device, so that hemostatic drugs can be sprayed through the working channel.

8. The bronchoscopic cryobiopsy and hemostasis integrated balloon catheter according to claim 7, characterized in that: The hemostatic drug injection device and the gas extraction and deflation device both use syringes.

9. The transbronchial cryobiopsy and hemostasis integrated balloon catheter according to claim 1, characterized in that: The drug balloon comprises an airbag main body and a plurality of folded parts connected to the airbag main body, wherein the airbag main body is sealed and connected to the outer wall of the catheter head end and forms a sealed space with the outer wall surface of the catheter head end, and the sealed space is communicated with the channel outlet of the balloon channel and the internal space of the folded parts; When not inflated, the airbag main body and the folded portion are both in a contracted state; when inflated, the folded portion and the airbag main body can both expand and unfold into a spherical state.

10. The transbronchial cryobiopsy and hemostasis integrated balloon catheter according to claim 9, characterized in that: The airbag main body and the folding part are both made of medical elastic material, and the outer surfaces of the airbag main body and the folding part are both provided with hemostatic drug particles.